BISFIL 2B is indicated for use as a base increment posterior composite. It is intended to be used with ALL-BOND 2ª or ONE-STEP", or similar universal dental adhesive system. BISFIL 2B will bond to the enamel / dentin bonding system such as ONE-STEP. BISFIL 2B is intended to be covered by a high quality light-cure composite.

Device Description

BISFIL 2B (directed shrinkage composite) is a self-cure, base increment, radiopaque composite recommended for the "directed shrinkage" posterior composite technique suggested by Dr. Raymond Bertolotti. BISFIL 2B begins curing adjacent to the naturally warmer surfaces of the dentin in the directed shrinkage technique. This is in contrast to light-cure composites which tend to begin curing towards the light source. Since all composites shrink on curing, the net effect of the directed shrinkage technique is to direct polymerization toward the tooth to help prevent formation of a marginal gap. BISFIL 2B is a naturally sticky, syringable composite that is intended to be overlaid with a condensable light-cure posterior composite such as AELITEFIL™ or BISFIL P". BISFIL 2B is intended to be used with ALL-BOND 2% or ONE-STEP", or similar universal dental adhesive system.

AI/ML Overview

This looks like a 510(k) summary for a dental composite material, not a medical device involving AI or complex performance criteria that would require the detailed study information requested. The document describes a traditional dental material (BISFIL™ 2B) and compares it to a predicate device (BISFIL™ II) based on chemical composition and mechanical properties, not diagnostic accuracy or AI performance.

Therefore, many of the requested fields are not applicable to the provided text. I will fill in the relevant available information and indicate where information is not present or not applicable.

Here's an attempt to answer the questions based on the provided text, while acknowledging its limitations for the requested format:

Acceptance Criteria and Device Performance Study (BISFIL™ 2B)

This submission describes a dental composite material, BISFIL™ 2B, intended for use as a base increment in posterior restorations. The document focuses on demonstrating substantial equivalence to a predicate device (BISFIL™ II) based on chemical composition, intended use, and general mechanical properties, rather than complex performance metrics typically associated with AI-driven medical devices or diagnostic tools.

As such, many of the typical acceptance criteria and study components requested for AI or diagnostic devices are not applicable or not detailed in this 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (dental composite) and the provided document, specific numerical "acceptance criteria" and "reported device performance" in the context of diagnostic accuracy (e.g., sensitivity, specificity) are not present. Instead, the document discusses concepts significant performance characteristics related to polymerization shrinkage and mechanical properties, and states that BISFIL™ 2B has similar properties to the predicate.

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Polymerization Shrinkage Management	Should reduce or overcome effects of polymerization shrinkage, especially leading to directed shrinkage towards the tooth surface, to prevent marginal gaps and stress.	BISFIL™ 2B overcomes problems due to higher resin content and ability to flow in paste/fluid state during early curing. Hypothesis of directed shrinkage towards warmer tooth surface is plausible (supported by Garberoglio et al.).
Chemical Composition	Nearly identical to predicate device (BISFIL™ II).	Silica and glass filled dimethacrylate composite. Resin compositions nearly identical to BISFIL™ II.
Filler Content / Viscosity	Similar to predicate, potentially with minor adjustments for intended flow.	BISFIL™ 2B has somewhat less filler and lower viscosity than BISFIL™ II.
Mechanical Properties	Appropriate for dental restoration, analogous to predicate.	Non-clinical tests similar to ISO 4049 and ADA #27. Diametral tensile testing and flexural modulus are important for characterizing strength. Explicit results or direct comparison to predicate values are not provided in this summary.
Radiopacity	Radiopaque (implied for composite use).	Explicitly stated as "radiopaque composite."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified in the provided summary. The document mentions "non-clinical tests" but does not detail the number of samples used for these tests (e.g., number of test specimens for diametral tensile strength or flexural modulus).
Data Provenance: Not specified. These would be lab-based mechanical and chemical tests, presumably conducted in-house or by a contract lab by BISCO, INC., in Itasca, IL, USA. The document does not refer to patient data or country of origin for such data.
Retrospective/Prospective: Not applicable. These are material characteristic tests, not clinical studies in the traditional sense.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable. For material characteristic tests, "ground truth" is established by laboratory measurement protocols and standards (e.g., ISO 4049, ADA #27).
Qualifications of Experts: The document references "leading clinicians (Dr. John Kanca, Middlebury, CT)" for predicate device recommendations and "Dr. Raymond Bertolotti" for originating the "directed shrinkage technique" hypothesis. These individuals are clinical experts whose concepts are discussed, but they are not described as establishing "ground truth" for specific test sets in the manner of diagnostic image interpretation. James L. Sandrik, PhD, appears to be the author or a key scientific figure from BISCO, INC. involved in the submission.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This concept is relevant for reconciling discrepancies in expert interpretations (e.g., in medical image reading). Material property testing relies on standardized measurement methods rather than expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. This is a material science submission, not a diagnostic or AI-assisted interpretation device. Therefore, no MRMC study was conducted or is applicable.
Effect Size of Human Readers with/without AI: Not applicable.

6. Standalone (Algorithm Only) Performance Study

Standalone Study Done: No. This product is a dental material, not an algorithm or AI system.

7. Type of Ground Truth Used

Type of Ground Truth: Not applicable in the conventional sense of clinical ground truth (e.g., pathology, outcomes data). For this submission, "ground truth" for performance characteristics would be established by:
- Standardized Laboratory Measurements: Adherence to established standards like ISO 4049 and ADA #27 for diametral tensile strength, flexural modulus, and chemical composition.
- Literature (Scientific Consensus/Hypothesis Plausibility): The document refers to scientific literature (e.g., Garberoglio) to support the plausibility of the "directed shrinkage" hypothesis.

8. Sample Size for the Training Set

Sample Size: Not applicable. This device is a material, not a machine learning model; therefore, it does not have a "training set."

9. How Ground Truth for the Training Set Was Established

How Ground Truth Was Established: Not applicable. This device is a material, not a machine learning model; therefore, it does not have a "training set" or corresponding ground truth.

Summary

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Ka64000

BISCO, INC., 1500 W. Thorndate Ave., Itasca, IL 60143 510(k) submission for BISFIL™ 2B

510(k) SUMMARY

As Required by the Safe Medical Devices Act of 1990

IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE

PREDICATE DEVICE

BISFIL™ II

BISFIL II is a self-cured, highly filled, radiopaque composite recommended for posterior restorations. The high filler concentration in BISFIL II (80%) results in improved abrasion resistance as well as high tensile and compressive strength. These are essential for composites to function effectively in the posterior properties segments. Optimum results require that BISFIL II be used in conjunction with a high quality dentin-enamel adhesive system such as ALL-BOND® 2 or ONE-STEP™

Leading clinicians (Dr. John Kanca, Middlebury, CT) have recommend that BISFIL II be used as the base increment, to replace dentin, underneath a light - cure restorative in the "directed shrinkage" technique. Being self - cured, BISFIL II tends to cure towards the warmth of the tooth, rather than towards a light source, to prevent development of a marginal gap.

DESCRIPTION OF THE APPLICANT COMPOSITE

BISFIL 2B begins curing adjacent to the naturally warmer surfaces of the dentin in the directed shrinkage technique. This is in contrast to light-cure composites which tend to begin curing towards the light source. Since all composites shrink on curing, the net effect of the directed shrinkage technique is to direct polymerization toward the tooth to help prevent formation of a marginal gap.

BISFIL 2B is a naturally sticky, syringable composite that is intended to be overlaid with a condensable light-cure posterior composite such as AELITEFIL™ or BISFIL P". BISFIL 2B is intended to be used with ALL-BOND 2% or ONE-STEP", or similar universal dental adhesive system.

INTENDED USES OF APPLICANT COMPOSITE

BISFIL 2B is indicated for use as a base increment posterior composite. It is
intended to be used with ALL-BOND 2ª or ONE-STEP", or similar universal dental adhesive system. BISFIL 2B will bond to the enamel / dentin bonding system such as ONE-STEP. BISFIL 2B is intended to be covered by a high quality light-cure composite.

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CONCEPTS SIGNIFICANT PERFORMANCE SCIENTIFIC and CHARACTERISTICS

There has been a great deal of discussion in the dental research literature over the effect of polymerization shrinkage on the quality of a dental restoration. On the one hand, older systems did not bond to tooth structure so shrinkage simply resulted in gap formation between the tooth and restoration resulting in leakage and recurrent caries. Modern materials, on the other hand, bond well to tooth structure. During shrinkage, pain may occur due to stress placed on the tooth, a cusp may actually fracture because of the stress, or the bond may break resulting in leakage.

In the absence of a true non-shrinking composite, several tricks have been used to reduce or overcome the effects of polymerization shrinkage. One of these is the "directed shrinkage technique" propose by Dr. Raymond Bertolotti (see references). Bertolotti proposed that a self-cure composite will produce less shrinkage stress because, during curing, the stress is relaxed in the presence of uncured material. As the material cures more of the paste is converted to solid until such time as no fluid phase is present to accommodate the shrinkage, at which time the stress accumulates quickly. Conversely, a light-cure composite cures very quickly and there is very little time for the paste to accommodate shrinkage.

BISFIL 2B overcomes the above problems because of its higher resin content and its ability to flow while in the paste/fluid state during the early stages of curing. In addition. Dr. Bertolotti hypothesized that the warmer surface of the tooth will tend to polymerize the material in contact with it. This effectively causes shrinkage to occur toward rather that away from the tooth as might occur with a light-cure material. This hypothesis has been tested by Garberoglio (see References, #7) and others and found plausible.

The chemical composition of BISFIL 2B and BISFIL II are very similar. Both are silica and glass filled dimethacrylate composites. The resin compositions of both products are nearly identical with BISFIL 2B having somewhat less filler and lower viscosity.

The non-clinical tests used for this submission are similar to those specified in ISO 4049 and American Dental Association #27. Diametral tensile testing is an accepted method to characterize the tensile strength of relatively brittle materials and the flexural modulus has become important recently in characterizing the strength in three point loading.

Sam L. Sandik

James L. Sandrik, PhD BISCO, INC. Itasca, IL 60143

October 4, 1996

Regulation Number and Section

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.